SERENACE LIQUID haloperidol 2 mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

haloperidol, Quantity: 2 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: methyl hydroxybenzoate; purified water; propyl hydroxybenzoate; lactic acid

Administration route:

Oral

Units in package:

100mL, 500mL, 15mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Chronic Therapy: The management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, Gilles de la Tourette syndrome. Short Term Therapy: The treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour. In the treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy. Neuroleptanalgesia

Product summary:

Visual Identification: A clear, colourless mobile liquid free from obvious visible contamination.; Container Type: Bottle; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-30

Patient Information leaflet

SERENACE Tablets and Liquid- Consumer Medicine Information
Page 1 of 6
SERENACE TABLETS AND LIQUID
_haloperidol _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SERENACE. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you taking SERENACE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SERENACE IS
USED FOR
SERENACE is used to treat mental
illnesses such as:
•
schizophrenia, an illness with
disturbances in thinking, feelings
and behaviour
•
mania, an illness where the
patient experiences episodes of
overactivity, elation or irritability
•
severe anxiety, tension or
excitement and severe agitation,
hyperactivity or aggression in
patients with mental or
emotional illness
It is also used to treat:
•
behavioural problems in children
with mental retardation or
mental illness
•
nausea and vomiting (caused by
cancer treatment)
•
anxiety and pain during surgery
_(neurolept anaesthesia) _
•
Tourette’s Syndrome, a
condition with uncontrolled vocal
outbursts and body movements
(tics)
•
Before you receive SERENACE,
your doctor may recommend
that you have an
electrocardiogram or ECG.
•
Your doctor may also
recommend that you have an
ECG on a regular basis while
taking SERENACE.
Your doctor may have prescribed
SERENACE for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SERENACE
HAS BEEN PRESCRIBED FOR YOU.
SERENACE belongs to a group of
medicines called antipsychotics. It
helps to correct chemical
imbalances in the brain, which may
cause mental illness. _These _
_chemicals may also affect the parts _
_of the brain, which control nausea _
_and vomiting._
There is no evidence that this
medicine is addictive or habit
formin

Summary of Product characteristics

Serenace tablets and liquid – Product information
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
SERENACE TABLETS AND LIQUID (HALOPERIDOL)
1.NAME OF THE MEDICINE
SERENACE tablets and liquid contain haloperidol.
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Serenace tablets contain either 0.5 mg, 1.5 mg, 5 mg or 20 mg
haloperidol as the active
ingredient. The tablets also contain lactose monohydrate, maize
starch, acacia, magnesium
stearate and calcium hydrogen phosphate dihydrate. In addition,
Serenace 0.5 mg tablets
contain quinoline yellow and green S, Serenace 5 mg tablets contain
brilliant scarlet 4R and
Serenace 20 mg tablets contain indigo carmine.
Serenace liquid contains 2 mg/mL haloperidol as the active ingredient.
The liquid also contains
lactic acid, purified water, with methyl hydroxybenzoate and propyl
hydroxybenzoate as
preservatives.
3.PHARMACEUTICAL FORM
Serenace tablets
0.5 mg tablet: A round, green, compressed tablet plain on one side and
scored on the other
side.
1.5 mg tablet: A round, white compressed tablet, plain on one side and
scored on the other
side.
5 mg tablet: A round, red compressed tablet plain on one side and
scored on the other side.
20 mg tablet: A light blue tablet, scored, uncoated, stamped "SEARLE"
on one side. This tablet
strength is currently not marketed.
Serenace oral liquid
2 mg/mL liquid: A clear, colourless mobile liquid free from visible
contamination. Available in
100 mL amber glass bottles with a white tamper evident child-resistant
polypropylene cap.
4.CLINICAL PARTICULARS
4.1THERAPEUTIC INDICATIONS
CHRONIC THERAPY
The management of manifestations of psychotic disorders such as
schizophrenia, psychosis
due to organic brain damage or mental deficiency, the manic phase of
manic depressive
illness, Gilles de la Tourette syndrome.
SHORT TERM THERAPY
The treatment of acute alcoholism for the relief of delusions,
hallucinations and confused
states, and for the control of accompanying tremulousness and
aggressive behaviour.
In the treatment of intractable nausea and vomiting